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Putting Naloxone Into Action!
College of Psychiatric and Neurologic Pharmacists (CPNP)
August 13, 2015 at 8:00 p.m. Eastern
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Target Audience
• The overarching goal of PCSS-O is to offer evidence-based
trainings on the safe and effective prescribing of opioid medications
in the treatment of pain and/or opioid addiction.
• Our focus is to reach providers and/or providers-in-training from
diverse healthcare professions including physicians, nurses,
dentists, physician assistants, pharmacists, and program
administrators.
• This activity is designed for pharmacists and other health care
professionals interested in expanding Overdose Education and
Naloxone Distribution (OEND) at their practice site.
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Planning Committee, Disclosures
The planners, managers, and faculty have nothing to disclose related to the content of this CE activity.
Off-Label Use: This educational activity may contain discussion of published and/or investigational uses
of agents that are not indicated by the FDA (see faculty information and disclosures). The opinions
expressed in the educational activity do not necessarily represent the views of CPNP and any
educational partners. Please refer to the official prescribing information for each product for discussion
of approved indications, contraindications, and warnings. Presentations will include discussion of off-
label, experimental, and /or investigational use of drugs or devices: naloxone IV used for intranasal
administration (off-label).
Disclaimer: Participants have an implied responsibility to use the newly acquired information to
enhance patient outcomes and their own professional development. Any procedures, medications, or
other courses of diagnosis or treatment discussed or suggested in this activity should not be used by
clinicians without evaluation of their patient’s conditions and possible contraindications on dangers in
use, review of any applicable manufacturer’s product information, and comparison with
recommendations of other authorities. Please refer to the official prescribing information for each
product for discussion of approved indications, contraindications, and warnings.
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Faculty, Disclosures (see contact emails following Resources list)
Chris Stock,
PharmD,
BCPP
Jef Bratberg,
PharmD, BCPS
Theo Pikoulas,
PharmD, BCPP
James Gasper,
PharmD, BCPP
Shannon
Saldaña, MS,
PharmD, BCPP
Affiliation George E Wahlen
VA Medical
Center and
University of Utah
Salt Lake City, UT
University of Rhode
Island College of
Pharmacy
Kingston, RI
Behavioral Health
Pharmacy
Programs
Community Care of
North Carolina
Raleigh, NC
California
Department of
Health Care
Services
Sacramento, CA
Intermountain
Healthcare
Salt Lake City, UT
No relevant
financial
relationships to
disclose.
X
X
X
X
X
Will discuss
off-label use of
intranasal
naloxone
X
X
X
X
X
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Educational Objectives
At the conclusion of this activity participants should be able
to: 1. Identify a model for overdose education and naloxone distribution
(OEND) that is most applicable to their practice setting.
2. Summarize patient overdose education (OE) elements that will fit best
in their practice setting.
3. Describe strategies to bill an insurance carrier for OEND in their
practice setting.
4. Describe strategies to overcome some of the barriers to developing
OEND in their practice setting.
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Participation Requirements
On or before August 20, participants in this course must complete an
examination and achieve a score of 70% or greater at
http://cpnp.org/ed/university/course/putting-naloxone-action. Successful
completion of the course also requires the completion of a course evaluation.
The ACPE universal program number assigned to the live course is
0284-0000-15-078-L04-P (1.0 contact hours).
Beginning August 21, the course will be available as home-study. Participants in
the home-study course must complete an examination and achieve a score of
70% or greater and complete a course evaluation. The ACPE universal program
number assigned to the home-study course is 0284-0000-15-078-H04-P
(1.0 contact hours).
ACPE credit will be awarded through CPE Monitor.
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Please ask questions!
During the live webinar, you can
click the Q&A button ( ) at
the top of the screen to send a
question to the moderator at any
time.
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Case of CB
Age: 50
Past medical history:
• Alcohol use disorder
(abstinent x 10 years)
• Panic disorder x 5 years
• HTN x 4 years
Past surgical history:
• L1-L4 Lumbar fusion 3 years
ago
• Wisdom teeth extracted 30
years ago
Medications:
• Oxycodone ER 30 mg/325 mg APAP po twice daily for chronic back pain (90 morphine mg equivalent)
• Clonazepam 0.5 mg po three times daily PRN anxiety
• Lisinopril 5 mg po daily
Social history:
• Occasional marijuana use as teenager
• Both parents alive and well, F 81, M 83
• Married x 25 years
• Lives with son, 21, opioid use disorder x 6 years (Rx heroin); recently released from detoxification program, suspected relapse
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Supporting Laws
• Medical and pharmacy practice laws and rules
Prescribing naloxone for legitimate patients is
allowable in all states
Prescribing naloxone for non-patients or “third parties”
likely requires special laws and rules including:
− Third party prescribing
− Liability protection
• Scope of practice
• Good Samaritan
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Models
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Naloxone Access Models
Green, Traci C., et al. "Orienting patients to greater opioid safety: models of community
pharmacy-based naloxone." Harm Reduction Journal 12.1 (2015): 25.
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By order of prescription from CB’s prescriber
How it works
Patients with overdose risks in your practice
(CB is at risk)
All pharmacy patients so they will ask their
prescriber to prescribe naloxone
Prescribers who treat those patients
(CB’s doctor)
Call prescriber to request naloxone
prescription when you see at risk patients
Supply prescriber with prescription forms and
‘at risk’ checklist
Pharmacist trains CB and her family in OD
prevention, identification, response and
naloxone kit administration & gives them
written naloxone handout
CB’s private insurance is successfully billed
for 2 prefilled naloxone syringes & she pays
generic drug copay plus ~$10 for 2 atomizers
Pharmacist logs Rx date dispensed,
manufacturer, and lot #
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Prescribers about overdose risks and
support for co-prescribing
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Coe,Walsh. Distribution of Naloxone for Overdose Prevention to Chronic Pain
Patients." Preventive Medicine (2015).
Bailey, Wermeling. Naloxone for Opioid Overdose Prevention Pharmacists’ Role in
Community-Based Practice Settings Annals of Pharmacotherapy (2014)
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Naloxone is an antidote sprayed into
the nose if you are too sleepy or can’t
be woken up due to these pain
medications.
Sample Patient
Materials (see Resource list)
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Sample Prescriber
Materials (see Resource list)
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Naloxone Access Models
Green, Traci C., et al. "Orienting patients to greater opioid safety: models of community
pharmacy-based naloxone." Harm Reduction Journal 12.1 (2015): 25.
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• The Collaborative Practice Agreement allows pharmacists to initiate naloxone therapy under a regulatory waiver from the RI Board of Pharmacy
• Pharmacist qualifications:
Possess an active Rhode Island Pharmacist license in good standing
CPR certified
Complete a appropriate training program containing:
− Identifying those who are at risk for opioid overdose
− Identifying the signs and symptoms of opioid overdose
− Use of naloxone in overdose situations
− Dispensing of naloxone pursuant to this protocol
− Naloxone administration techniques
− Patient and caregiver counseling regarding the use of naloxone and overdose response steps
Collaborative Practice Agreement
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CPA Continuing Professional Education
Requirements
• Pharmacist shall complete 1 hour of ACPE-accredited continuing professional education annually in the area of practice covered by the agreement
• Continuing Education may include any of the following areas related to the safe prescribing of opioids:
Opioid overdose prevention
Reducing the risk of prescription opioid abuse
The safe use of opioids for the management of chronic pain
The use of screening tools to detect opioid abuse or dependency, specialist referrals and management of difficult patients
Preventing diversion of prescribed opioid medications
Treating patients with pain and addiction
Naloxone administration technique
Review of collaborative practice agreement
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• Voluntarily requesting
Does not have to be someone at risk of overdose- can be a
friend, family member, etc.
• Recipient of emergency medical care for acute opioid poisoning
• Suspected illicit or nonmedical opioid user
• High dose opioid prescription (>100 morphine mg equivalent daily)
• Prescription for a long acting/extended release opioid
• Methadone prescription to opioid naïve patient
Eligible patients to participate
Kinner SA, Milloy M-J, Wood E, Qi J, Zhang R, Kerr T. Incidence and risk factors for non-fatal
overdose among a cohort of recently incarcerated illicit drug users. Addictive Behaviors.
2012;37(6):691-696.
Dunn KM, Saunders KW, Rutter CM, et al. Opioid prescriptions for chronic pain and overdose:
a cohort study. Ann Intern Med. 2010;152(2):85-92.
Substance Abuse and Mental Health Services Administration. SAMHSA Opioid Overdose
Prevention Toolkit. HHS Publication No (SMA) 14-4742.
Rockville, MD: Substance Abuse and Mental Health Services Administration, 2014.
Wolff K. Characterization of methadone overdose: clinical considerations and the scientific
evidence. The Drug Monit. 2002;24(4):457-470.
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• Opioid prescription and:
History of smoking
COPD
Respiratory illness or obstruction
Renal dysfunction or hepatic disease
Known or suspected concurrent alcohol abuse
Concurrent benzodiazepine prescription
Concurrent SSRI or TCA anti-depressant prescription
Eligible patients to participate
(Highest Risk)
Jann, M., Kennedy, W.K., Lopez, G., 2014. Benzodiazepines: a major component in
unintentional prescription drug overdoses with opioid analgesics. J. Pharm. Pract.
27 (1), 5–16.
Mack KA, Zhang K, Paulozzi L, Jones C. Prescription Practices involving Opioid
Analgesics among Americans with Medicaid, 2010. J Health Care Poor
Underserved 2015;26(1):182-98.
Zedler B, Xie L, Wang L, et al. Risk factors for serious prescription opioid-related
toxicity or overdose among Veterans Health Administration patients. Pain Med.
2014;15(11):1911-29. doi: 10.1111/pme.12480.
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• Recently released prisoners from a correctional
facility
• Released from opioid detoxification or
mandatory abstinence program
• Patients newly entering a methadone maintenance
treatment program
• Patients that may have difficulty accessing
emergency medical services
Eligible patients to participate
(Highest Risk)
Moller LF, Matic S, van den Bergh BJ, Moloney K, Hayton P, Gatherer A. Acute
drug-related mortality of people recently released from prisons. Public Health.
2010;124(11):637-639. doi: 10.1016/j.puhe.2010.08.012.
Strang J, McCambridge J, Best D, et al. Loss of tolerance and overdose
mortality after inpatient opiate detoxification: follow up study. BMJ.
2003;326(7396):959-960.
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Contraindications
• A history of a known hypersensitivity to naloxone or any
of its components
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Prior to providing services to patients pursuant to this
CPA, the pharmacy will obtain informed consent from
each patient, which shall include:
A signed authorization for the release of protected health information
by and between the pharmacy and the Collaborating Physician
A provision allowing the patient to withdraw at any time from the
collaborative practice described in this CPA
An acknowledgment that patient has been offered the education and
training described in Section 6 of the CPA
Pharmacy will retain a copy of the informed consent
Protocol: Informed Consent
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• The pharmacist shall initiate a naloxone prescription pursuant
to the protocol described, and issue that prescription in the
name of the collaborating medical provider participating in
this CPA
• The pharmacist shall contact the physician entered in the
CPA in the event that medical consultation is required for a
particular patient
Protocol: Procedure
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• Intramuscular injection into deltoid muscle Naloxone HCl solution 0.4mg/ml 1 ml single use vial
− Dispense 2 (two) vials
− 2 (two) syringes - OR -
Naloxone HCl solution 0.4mg/ml 10 ml multi-dose vial − 1 (one) vial
− 9 (nine) syringes
• Intranasal Naloxone HCl solution 1mg/1ml prefilled 2 ml Luer-Jet
syringes − 2 (two) pre-filled syringes
− At least 1 (one) nasal drug delivery device
• No refills - Total amount dispensed not to exceed 10 mL
Protocol: Dispensing
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• IM syringes
o 1-1.5”, 21-23 gauge needle, with a
syringe capacity of 1-3mL
• A nasal mucosal atomization
device or devices must be
dispensed with the Luer-Jet
syringes without needles for
intranasal use
Protocol: Dispensing
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Protocol: Education
• Before receiving naloxone patients must have overdose prevention, identification, and response training
o Purpose for naloxone
o Correct naloxone administration
o Precautions regarding interacting medications
o Identifying and avoiding high risk situations for overdose
o Risk reduction strategies
• Opioid Overdose Response
o How to identify an overdose
o Rescue breathing
o Calling 9-1-1
o How to administer naloxone (either IM or IN)
o What to do and expect after naloxone administration (withdrawal, rescue position)
Green T, Bratberg J, Dauria E, Rich J. Responding to Opioid Overdose in
Rhode Island: Where the Medical Community Has Gone and Where We Need
to Go. R I Med J (2013). 2014;97:29-33.
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• Record the date the prescription was dispensed, the manufacturer and lot number, and the name and title of the person providing medication and education
• Alert the physician entered into the collaborative practice agreement via fax when naloxone is dispensed within 7 days
• Maintain records for minimum of 5 years
Informed consent
Re-fill form
Log of monthly activity
Staff / CPA prescriber will review monthly
• Licensing and liability insurance information of participating pharmacist(s) and prescriber (s) will be maintained
• Protocol shall remain in effect until rescinded or for 2 years after the effective date
Protocol: Documentation
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How it works
CB requests naloxone for her son from
Overdose Trained Pharmacist
CB completes and signs an informed
consent authorizing release of her PHI to
Collaborating Prescriber
CB is identified as being in contact with
someone at risk and/or at risk herself for
opioid overdose
Naloxone formulations discussed with CB
and she chooses intranasal
Pharmacist Initiates naloxone prescription
with collaborating prescriber as prescriber
and CB as patient
Pharmacist trains CB in OD prevention,
identification, response and naloxone kit
administration & gives her written naloxone
handout
CB’s private insurance is successfully billed
for 2 prefilled naloxone syringes & she pays
generic drug copay plus ~$10 for 2 atomizers
Rx & consent faxed to Collaborating
Prescriber within 7 days
Pharmacist logs Rx date dispensed,
manufacturer, and lot #
Re
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isp
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Naloxone Access Models
Green, Traci C., et al. "Orienting patients to greater opioid safety: models of community
pharmacy-based naloxone." Harm Reduction Journal 12.1 (2015): 25.
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Standing Order Model
• A standing order is a written instruction issued by a
medical practitioner that authorizes a specified person or
class of people, who do not have prescribing rights, to
administer and/or dispense naloxone to a patient who
may be unknown to the prescriber at the time of the
order
Used to improve a patient’s timely access to
medicines
Eliminates the need for hand-written, faxed, or phoned
prescription
Collaborative model
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States With Standing Order Legislation
As of June 2015, 27 states have legislative language that
allows for standing orders
• AL
• CA
• CO
• DE
• IL
• IN
• KY
• LA
• ME
• MN
• MS
• NC
• ND
• NH
• NJ
• NV
• NY
• PA
• RI
• SC
• TN
• TX
• VT
• VA
• WA
• WI
• WV
Davis, C. Legal Interventions to Reduce Overdose Mortality: Naloxone Access and Overdose Good Samaritan Laws. Last updated June, 2015.
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NC Standing Order Legislation
• Third party prescribing
• “Immune from any civil or criminal liability”
Practitioner who prescribes naloxone
Any person who administers naloxone
• Effective August 1, 2015
Specifies that NC pharmacists can dispense under standing order
Specifies that NC pharmacists are immune from any civil or criminal liability
• Encourages bystanders to contact emergency responders without fear of arrest
Senate Bill 154. General Assembly of NC, Session 2015.
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NC Specifics
• Pharmacist Qualifications:
Possess active NC pharmacist license
• No mandated pharmacist training
• No specific criteria required for receiving naloxone
• Pharmacist can dispense intranasal, IM, or auto-injector
as specified by the standing order
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How it works
CB requests naloxone for her son at
Pharmacy X
Pharmacy X sets up a standing order with
Physician Y or Health Department Z
CB is identified as being in contact with
someone at risk and/or at risk herself for
opioid overdose
Pharmacist initiates naloxone RX with
standing order physician as prescriber and
CB as patient
Since intranasal naloxone is specified on
standing order, this formulation is discussed
with CB
Pharmacist trains CB in OD prevention,
identification, response and naloxone kit
administration & gives her written naloxone
handout
CB’s private insurance is successfully billed
for 2 prefilled naloxone syringes & she pays
generic drug copay plus ~$10 for 2 atomizers
Pharmacist notifies standing order physician
as a courtesy when complete
Pharmacist processes/dispenses RX
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Naloxone Access Models
Green, Traci C., et al. "Orienting patients to greater opioid safety: models of community
pharmacy-based naloxone." Harm Reduction Journal 12.1 (2015): 25.
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Pharmacist-as-Prescriber
Requirements and common themes
• Pharmacist independently makes the decision about the
appropriateness of naloxone
• Adopted by statewide protocol approved by the Board of
Pharmacy, Medical Board, and other invested parties
• Example States: NM, CA, ID, VT, NV
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Pharmacists-as-Prescriber
New Mexico
• 2 hour Board Approved CE
• Screening of patient
• Patient consent
• Patient education
• Primary care notification
• Prescription record
• Documentation of why naloxone was used
California
• 1 hour CE or eq from School of Pharmacy
• Allows “furnishing” without a prescription
• Screening of recipient/bystander
• Patient education
• Primary care notification
• Record of dispensing
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How it works
CB requests naloxone for her son
from Pharmacist
CB is identified as being in contact
with someone at risk
Naloxone formulations discussed with
CB and she chooses intranasal
• CB is trained
• Prescription for CB recorded in pharmacy
software
• She pays cash for 2 atomizers, 2 prefilled
syringes, and professional fee
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In a Health System
• Not-for-profit health system includes
22 hospitals
>185 clinics
25 Community Pharmacies
Health insurance plan
• UT Naloxone access, Good Samaritan legislation in 2014
• Leadership decision to make naloxone rescue kits
available in all 25 Community Pharmacies in Feb 2015
• Community Pharmacists trained in 30-minute interactive
presentation prior to kit availability to the public
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In a Health System
• Rescue kits assembled in central supply chain center
and distributed to Community Pharmacies
IM and IN: 2 naloxone doses, 2 syringes or atomizers
Instructions from prescribetoprevent.org
Utah Department of Health Prescription Drug
Overdose Pocket Card*
• Dispensing for outpatient use must take place in
Community Pharmacy, pursuant to a prescription
* Pocket Card available at
http://www.health.utah.gov/vipp/pdf/RxDrugs/rxdrug-overdose-pocketcard.pdf
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In a Health System
• CPA between licensed prescriber(s) and pharmacist(s)
Permitted by Utah Pharmacy Practice Act
No state-mandated restrictions
“Required” education and training are established by
the parties engaging in the collaboration
As in other states, pharmacists may initiate naloxone
overdose kit distribution and educate patients
according to an approved protocol
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In a Health System
• Health insurance plan
Auto-injector covered: tier 3, non-preferred, prior
authorization required
Kits were not recognized; NDC for naloxone
corresponded to medical benefit
Petitioned health insurance plan to add naloxone
rescue kits to prescription drug formulary
P&T approved kit coverage to begin July 2015
• Health care system is not-for-profit
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Strategies to Overcome Barriers
• Billing and
reimbursement
o Cash
o Medicaid
o Third-party – insurance
For enrolled patient
For non-enrolled
• Atomizers
o Ordering
o Billing
o Compounding
• Stigma
o Most naloxone reversals
involve heroin use.
o Rx opioid overdoses
account for twice those
from heroin.
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Patient Education
• How do you reach people who may witness prescription
opioid analgesic overdoses?
• Avoid stigma: “Overdose” may turn off or scare them
− Stigma and association with drug abuse or
‘addicts’
• Non-judgmental, less scary, use their language
“Has your spouse ever mentioned you snoring or
being hard to awaken?”
“I want to improve the safety of your pain medications”
“In case you have an unexpected reaction”
“Just in case” – like having a fire extinguisher in your
home
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Resources
1) Your own state’s board of pharmacy – CPA’s, Standing
Orders, Protocols
2) Videos, ordering information, prescription forms, etc:
− http://cpnp.org/guideline/naloxone
− www.prescribetoprevent.org
− www.stopoverdose.org
− www.getnaloxonenow.org
Example of overdose pocket card available at
http://www.health.utah.gov/vipp/pdf/RxDrugs/rxdrug-
overdose-pocketcard.pdf
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Faculty Contacts
• Jeffrey Bratberg [email protected]
• James Gasper [email protected]
• Theo Pikoulas [email protected]
• Shannon Saldana [email protected]
• Chris Stock [email protected]
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PCSS-O Colleague Support Program
and Listserv
• PCSS-O Colleague Support Program is designed to offer general information to health
professionals seeking guidance in their clinical practice in prescribing opioid
medications.
• PCSS-O Mentors comprise a national network of trained providers with expertise in
addiction medicine/psychiatry and pain management.
• Our mentoring approach allows every mentor/mentee relationship to be unique and
catered to the specific needs of both parties.
• The mentoring program is available at no cost to providers.
• Listserv: A resource that provides an “Expert of the Month” who will answer questions
about educational content that has been presented through PCSS-O project. To join
email: [email protected].
For more information on requesting or becoming a mentor visit:
www.pcss-o.org/colleague-support
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PCSS-O is a collaborative effort led by American Academy of Addiction Psychiatry (AAAP) in partnership
with: Addiction Technology Transfer Center (ATTC), American Academy of Neurology (AAN), American
Academy of Pain Medicine (AAPM), American Academy of Pediatrics (AAP), American College of
Physicians (ACP), American Dental Association (ADA), American Medical Association (AMA), American
Osteopathic Academy of Addiction Medicine (AOAAM), American Psychiatric Association (APA), American
Society for Pain Management Nursing (ASPMN), International Nurses Society on Addictions (IntNSA), and
Southeast Consortium for Substance Abuse Training (SECSAT).
For more information visit: www.pcss-o.org
For questions email: [email protected]
Twitter: @PCSSProjects
Funding for this initiative was made possible (in part) by Providers’ Clinical Support System for Opioid Therapies (grant no. 1H79TI025595) from SAMHSA. The
views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department
of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.
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College of Psychiatric and
Neurologic Pharmacists (CPNP)
The College of Psychiatric and Neurologic Pharmacists (CPNP) is an association of specialty
pharmacists who work to improve the minds and lives of those affected by psychiatric and neurologic
disorders. These professionals apply their clinical knowledge in a variety of healthcare settings and
positions ranging from education to research with the goal to apply evidence-based, cost efficient
best practices in achieving patient recovery and improving quality of life.
Psychiatric pharmacists are uniquely qualified to work with opioid use disorder patients and are
experts in medication use and abuse/diversion. Psychiatric pharmacists receive graduate
professional pharmacy degrees and many hold doctorates. They also receive post-graduate
residency training in psychiatry and substance abuse or have equivalent work experience.
Psychiatric pharmacists are eligible to become board certified psychiatric pharmacists (BCPP) by
completing required prerequisites and a rigorous national exam.
For more information visit cpnp.org
Contact us at [email protected]
View the CPNP Naloxone Access Guideline Document at http://cpnp.org/guideline/naloxone